syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
Reported: May 4, 2022 Initiated: March 7, 2022 #Z-0994-2022
Product Description
syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
Reason for Recall
Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 1 (US)
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, IL, IN, KY, MD, MO, ND, NH, NY, OH, OR, PA, SD, TX, VA and the countries of Argentina, Austria, Bahrain, Belgium, Brazil, Czechia, Denmark, France, Germany, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Switzerland, United Kingdom.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 1 (US).
Why was this product recalled? ▼
Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 4, 2022. Severity: Moderate. Recall number: Z-0994-2022.
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